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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHydrus® Microstent
Generic NameIntraocular pressure lowering implant
ApplicantAlcon Research, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP170034
Supplement NumberS018
Date Received05/07/2026
Decision Date06/04/2026
Product Code OGO 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for an alternative raw material supplier for Nitinol (NiTi) Tubing
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